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Urine Uric Acid

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301. Lonquex - lipegfilgrastim

., EJC, 2006; 42: 2433-53). Evidence from multiple randomised trials supports the benefit of primary prophylaxis in reducing the frequency of hospitalisation for antibiotic therapy, documented infection, and rates of neutropenic fever in adults. The impact on survival is less clear (Kuderer et al., J. Clin Oncol 2007; 25:3158). Recombinant hG-CSF (filgrastim) has been introduced in clinical use since 1991 under the trade name Neupogen. Recombinant hG-CSF is produced in E. coli. Its amino acid (...) dose after each (generally weekly) chemotherapy cycle rather than daily administration. About the product The natural human granulocyte colony stimulating factor (G-CSF) is a glycoprotein composed of a single polypeptide chain of 174 or 177 amino acids and is glycosylated at Threonin133 (Thr133). It: • regulates the proliferation and differentiation of progenitor cells within the bone marrow and the release of mature neutrophils into the peripheral blood • is a positive regulator of granulopoiesis

2013 European Medicines Agency - EPARs

302. Krystexxa - pegloticase

assessment report EMA/CHMP/697253/2012 Page 5/101 Medicinal product no longer authorised2. Scientific discussion 2.1. Introduction Problem statement Uric acid is the end metabolite in the purine catabolic pathway in humans. In most species, except the great apes, urate oxidase catalyzes the conversion of uric acid to allantoin. Uric acid, which is poorly soluble in water, is excreted in the urine. When the concentration of serum uric acid (SUA) is above the biochemical limit of solubility, 6.8 mg/dl, i.e (...) Monomethoxypoly(ethylene glycol) mPEG-NPC p- nitrophenylcarbonate derivative of mPEG MS Mass spectrometry MW Molecular Weight PUA Plasma uric acid RI Refractive Index SOP Standard Operating Procedure SUA Serum uric acid UA Uric acid UV Ultraviolet Krystexxa CHMP assessment report EMA/CHMP/697253/2012 Page 3/101 Medicinal product no longer authorised1. Background information on the procedure 1.1. Submission of the dossier The applicant Savient Pharma Ireland Ltd. submitted on 3 May 2011 an application

2013 European Medicines Agency - EPARs

303. Tasimelteon (Hetlioz)

melatonin metabolite concentration in the urine occurs about 3.5 hours prior to waking. The main metabolite of melatonin in the urine is 6-sulfatoxymelatonin (aMT6s). Non-24 Hour Disorder is a chronic disorder that occurs when individuals are unable to synchronize their endogenous body clock to the 24-hour light-dark cycle. The Applicant states that Non-24 Hour Disorder is also known as: Circadian rhythm sleep disorder – nonentrained type; Free running disorder; Non-24-hour circadian rhythm disorder (...) estimation segment and a variable-length in-phase transition segment. During the t estimation segment, urine samples were collected over a 48 hour period every week for 4 weeks to calculate the t (see next section of this review for details). The purpose of the Pre-randomization phase was to allow time for the subject’s circadian rhythm to be aligned with the subject’s target bedtime, as assessed by urinary 6-sulfatoxymelatonin (aMT6s) rhythms (see next section for details). The Applicant states

2013 FDA - Drug Approval Package

304. Dalbavancin hydrochloride (HCl) (Dalvance)

of therapy At 42-72 hours after initiation of treatment Primary efficacy endpoint population Clinically evaluable Intent-to-treat Area of cellulitis of >75cm 2 for all subtypes of infection Not required as an inclusion criterion Required as an inclusion criterion Subjects with urine output of 2x the upper limit of normal Excluded Allowed Reference ID: 3481080Clinical Review Dmitri Iarikov, MD, PhD NDA 21883, 505 (b)(1) DALVANCE (dalbavancin hydrochloride) 36 Table 8: Key differences in the design

2013 FDA - Drug Approval Package

306. Risk factors for early chronic kidney disease

combined haematuria and proteinuria and 3% had elevated serum creatinine levels (=100 µmol/l in women and =115 µmol/l in men). A subsequent cross-sectional study of 129 patients with rheumatoid arthritis observed that the prevalence of stages, 1, 2, 3, 4 and 5 CKD were 11%, 20%, 15%, 0% and 0%, respectively [160]. These estimates may be inaccurate because the presence or absence of proteinuria was based on a single urine sample. Cancer Patients with malignancy can develop CKD via a variety (...) Epidemiologici in Nefrologia (GISEN). Ramipril Efficacy in Nephropathy. Lancet. 1998; 352: 1252-6. 66. Newman DJ, Mattock MB, Dawnay ABS et al. Systematic review on urine albumin testing for early detection of diabetic complications. Health Technology Assessment (Winchester, England). 2005; 9: iii-vi. 67. Orchard TJ, Dorman JS, Maser RE et al. Prevalence of complications in IDDM by sex and duration. Pittsburgh Epidemiology of Diabetes Complications Study II. Diabetes. 1990; 39: 1116-24. 68. Parving HH

2013 KHA-CARI Guidelines

307. Modification of lifestyle and nutrition interventions for management of early chronic kidney disease

therapy. Once blood pressure is controlled, low-dose acetylsalicylic acid therapy should be considered. _______________________________________________________________________________________________________________________ Early Chronic Kidney Disease July 2012 Page 20 of 50 SUGGESTIONS FOR FUTURE RESEARCH 1. An RCT of different levels of fluid intake ( 3L/day) on CKD progression in patients with stage 1-3 CKD. 2. A study of the impact of moderation of alcohol intake on CKD progression in patients (...) . Conservative treatment with ketoacid and amino acid supplemented low-protein diets in chronic renal failure. American Journal of Clinical Nutrition. 1980; 33: 1667-72. 24. Maschio G, Oldrizzi L, Tessitore N et al. Effects of dietary protein and phosphorus restriction on the progression of early renal failure. Kidney International. 1982; 22: 371-6. 25. Maschio G, Oldrizzi L, Tessitore N et al. Early dietary protein and phosphorus restriction is effective in delaying progression of chronic renal failure

2013 KHA-CARI Guidelines

308. KHA-CARI Guideline: Early chronic kidney disease: Detection, prevention and management

-platelet therapy Guideline recommendations a. We suggest that aspirin therapy should not be routinely recommended as the risk : bene?t for primary prevention of CVDinpatientswithearly(stage1–3)CKDisuncertain(2C). 17. Medical therapies to reduce chronic kidney disease progression and cardiovascular risk: uric acid-lowering agents Guideline recommendations a. We suggest that use of uric acid lowering agents (such as allopurinol, rasburicase or feboxostat) should not be rou- tinely recommended in people (...) . Hyperuricaemia – where nephrology meets rheumatology. Rheumatology 2008; 47 (7): 960–64. 41. Badve SV, Brown F, Hawley CM et al. Challenges of conducting a trial of uric-acid-lowering therapy in CKD. Nat. Rev. Nephrol. 2011; 7 (5): 295–300. 42. Sturm G, Kollerits B, Neyer U, Ritz E, Kronenberg F. Uric acid as a risk factor for progression of non-diabetic chronic kidney disease? The Mild to Moderate Kidney Disease (MMKD) Study. Exp. Gerontol. 2008; 43: 347–52. 43. Ravani P, Malberti F, Tripepi G et al

2013 KHA-CARI Guidelines

310. Forxiga - dapagliflozin

(comparators were metformin XR and glipizide) in drug-naïve subjects at an early stage of disease and subjects who require additional therapy after failure to reach adequate glycaemic control with their current regimen, including oral anti-diabetic agents or insulin at a later stage of the disease. The clinical development program also examined the persistent loss of calories in the urine due to glucosuria and the resulting potential for weight loss with a reduction in total body fat. The clinical studies (...) leads to the excretion of glucose in the urine, and only in diabetic animal models lower blood glucose in a manner independent of insulin secretion or insulin action, without hypoglycaemia. Primary pharmacodynamic in vitro The Applicant demonstrated dapagliflozin’s activity towards human, rat and mouse SGLT2 in vitro (artificial overexpression of the respective transporters in Chinese hamster ovary (CHO) cells) and thereby also verified the suitability of the rodent models used for further studies

2012 European Medicines Agency - EPARs

311. Bretaris Genuair (aclidinium bromide, micronised)

( t) at steady state AV Atrioventricular BChE Butyrylcholinesterase BDI Baseline Dyspnoea Index BID Twice daily BMI Body mass index CI Confidence interval Cmax Peak plasma concentration COPD Chronic obstructive pulmonary disease CV Coefficient of variation CYP450 Cytochrome P450 DPI Dry powder inhaler ECG Electrocardiogram EMA European Medicines Agency F Absolute bioavailability expressed in % fe Percentage of dose excreted in urine FEV 1 Forced expiratory volume in 1 second FRC Forced residual (...) . The re-test and storage conditions for the unmicronised active substance intermediate is also fully supported by the stability data provided. Forced degradation studies exposing the active substance to acid, base, aqueous, oxidative and high intensity light conditions have also been performed demonstrating that the active substance is sensitive to basic, acidic and oxidative conditions . The photo stability study was performed according to ICH Q1B and also demonstrated that aclidinium bromide

2012 European Medicines Agency - EPARs

312. Xaluprine (previously Mercaptopurine Nova Laboratories)

synt interconversion reactions, whereas the nucleotide triphosphate metabolites are in into nucleic acids. The relative contribution of each of these actions to the mechanism of cytotoxi unclear. 6-MP is converted to monophosphate forms by hypoxanthine-guani transferase (HGPRT). The ribonucleotide monophosphate inhibits the first step synthesis catalyzed by gl hesis and purine corporated directly city is ne phosphoribosyl of de novo purine utamine phosphoribosylpyrophosphate aminotransferase (...) monitored haematotoxicity and the dose should be carefully adjusted to suit the individual patient in accordance with the employed treatment conversion of inosinic acid to adenylic acid or to guanylic acid. Inhibition of purine n leads to the buildup of 5'-phosphoribosyl-1-pyrophosphate, which facilitates the act 6-TG to their active nucleotide forms by HGPRT. Both thiopurine r deoxyribonucleotide metabolites are formed, which can then be incorporated into DNA correlates with cytotoxicity. The efficacy

2012 European Medicines Agency - EPARs

313. Jakavi - ruxolitinib

. In Long-Evans (pigmented) rats, the highest concentrations of radioactivity were in the tissues and contents of the gastrointestinal tract, followed by urine, bile, uveal tract, liver, renal medulla, renal cortex, skin (pigmented), and kidney. Penetration of ruxolitinib and ruxolitinib-derived radioactivity into central nervous system tissues was limited (less than 10% of plasma concentration). Disappearance of radioactivity was rapid and complete in most tissues in albino and pigmented rats (...) (less than 3% based on 14C-AUC) is well below the threshold that would raise a safety concern. The animals in the toxicity studies have thus been exposed to the major human metabolites. Excretion In rats, excretion of drug-derived radioactivity was rapid after either a single oral or i.v. dose of [14C] ruxolitinib (92% and 87%, respectively, excreted in urine and faeces within 12 h of dosing). Excretion in urine, bile, and faeces of bile duct cannulated rats accounted for approximately 50%, 37

2012 European Medicines Agency - EPARs

314. Eklira Genuair - aclidinium bromide

Index BID Twice daily BMI Body mass index CI Confidence interval Cmax Peak plasma concentration COPD Chronic obstructive pulmonary disease CV Coefficient of variation CYP450 Cytochrome P450 DPI Dry powder inhaler ECG Electrocardiogram EMA European Medicines Agency F Absolute bioavailability expressed in % fe Percentage of dose excreted in urine FEV 1 Forced expiratory volume in 1 second FRC Forced residual capacity FVC Forced vital capacity GOLD Global initiative for Chronic Obstructive Pulmonary (...) provided. The specification and the analytical methods used in the stability studies are the same as those for release analysis testing. The re-test and storage conditions for the unmicronised active substance intermediate is also fully supported by the stability data provided. Eklira Genuair CHMP assessment report EMA/CHMP/169578/2012 Page 9/72 Forced degradation studies exposing the active substance to acid, base, aqueous, oxidative and high intensity light conditions have also been performed

2012 European Medicines Agency - EPARs

315. Alogliptin and alogliptin/pioglitazone

with a high-fat meal, alogliptin may be administered with or without food. It is well distributed into tissues and negligibly bound Reference ID: 3247308 (b) (4)Clinical Review Valerie S.W. Pratt, M.D. NDAs 22-271 and 22-426 Nesina (alogliptin) and (alogliptin/pioglitazone FDC) 24 to plasma proteins (20%). Alogliptin does not undergo extensive metabolism and 60- 71% of the dose is excreted as unchanged drug in the urine. Following oral administration of pioglitazone hydrochloride, peak concentrations

2012 FDA - Drug Approval Package

317. Hydrocodone Bitartrate Extended Release Capsules (Zohydro ER)

, read, write and understand English. 10. Female subjects of childbearing potential must have a negative urine pregnancy test at the Screening Visit, and must use a medically acceptable method of contraception. 11. Subjects must provide written informed consent. 12. Subjects must be able to complete study procedures Exclusion Criteria: Patients were to have been excluded if any of the following applied: 1. Any clinically significant condition that would preclude study participation or increase (...) investigational drug within 30 days of the Screening visit 17. Have used a monoamine oxidase inhibitor within 14 days prior to the start of study medication 18. History of any illicit substance or alcohol abuse in the past 5 years or any history of opioid abuse 19. Positive urine drug screen for illicit drugs, or non-prescribed controlled substances Treatment Phase Inclusion Criteria For entry into the Treatment Phase subjects were to have met all of the following criteria. 1. Stabilized on at least 20 mg BID

2012 FDA - Drug Approval Package

318. Teriflunomide

baseline Analyte Placebo Ter 7 Ter 14 Uric acid (range 125-428 umol/L) -3.8 -58.3 -77.8 CK (0-190 U/L) (measured only in 2001) -2.89 -2.62 +10.77 LDH (range 0-479 U/L) (measured only in 2001) -0.43 +17.89 +15.98 ALT (range 6-34 U/L) 0.009 0.112 0.095 WBC (range 3.8-10.7 GIGA/L) 0.01 -0.67 -0.85 Neutrophils (range 1.96-7.23 GIGA/L) 0.00 -0.47 -0.59 Lymphocytes (range 0.91-4.28 GIGA/L) 0.00 -0.22 -0.28 Hemoglobin (range 116-164 G/L) -1.3 -1.9 -2.4 Platelets (range 140-400 GIGA/L) 8.2 -14.1 -14.7 (...) In general, these changes tend to occur early (within the first 6-12 weeks) and then remain stable. Reference ID: 3185084 19 Outliers The following chart displays the percent of patients who met criteria for potentially clinically important changes for the various laboratory analytes: Analyte Placebo Ter 7 Ter 14 Phosphorus >0.6 and 0.3 and 7 mmol/L 0.2% 1% 1% Creatinine >150 umol/L 0% 1% 1% > 2 X baseline 0% 1% 1% > 3 x Baseline 0% 1% 1% Uric acid 3 - 2.5 - 0.5 5% 10% 4.5% Lymphocytes 0.5 Giga/L 5% 7

2012 FDA - Drug Approval Package

319. Spleen-Kidney Supplementing Formula Alleviates Renal Fibrosis in Diabetic Rats via TGF-<i>β</i>1-miR-21-PTEN Signaling Pathway. Full Text available with Trip Pro

model was induced by high-fat diet and multiple injections of low-dose streptozotocin. After 8-week intervention, samples were collected for detection.SKSF decreased fasting blood glucose, glycosylated hemoglobin A1c, blood urea nitrogen, uric acid, urea, 24-hour urine protein, and KW/BW ratio, while it increased creatinine clearance rate of T2DM rats. Meanwhile, SKSF attenuated the renal fibrosis and improved the morphology and structure of renal tissue. Furthermore, SKSF significantly reduced

2018 Evidence-based Complementary and Alternative Medicine (eCAM)

320. Endothelium Corneum Gigeriae Galli extract inhibits calcium oxalate formation and exerts anti-urolithic effects. (Abstract)

extract actually showed anti-urolithic effects; the incidence rates of crystal formation in the kidney in the model, low, middle and high dose groups were 100%, 90%, 70% and 60%, respectively, with a dose-dependent alleviation of kidney stone amounts and kidney damage. Treatment with middle and high ECGG extract doses significantly decreased urine uric acid and oxalic acid amounts, serum creatinine, urea nitrogen and uric acid contents, and kidney tissue oxalic acid and calcium levels, while (...) orally. After treatment, urine, serum and kidney bioindicators were analyzed, as well as kidney's pathological features.In the presence of ECGG extract, calcium oxalate dihydrate (COD) crystals with typical tetragonal bipyramidal morphology were obtained; meanwhile, the formation of calcium oxalate monohydrate (COM), a major urinary stone component, was inhibited; in addition, the equilibration time of the chemical reaction of Ca2+ and C2O42- ions was delayed in a concentration dependent manner. ECGG

2018 Journal of Ethnopharmacology

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